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Probably not the capsule, kayak wench
Do you doubt that taking Eli200 without the capsule will result in the drug being absorbed at the normal rate? I figured it was the capsule slowing the absorption. Could it be the greasy meal? But that would mean whatever barrier the beads have were mucking things up. Is that a real possibility?
Dear WeeZuhl,
I come in need of some education. What does Nasrat mean when he is talking about sprinkling our drug on food? Is he saying to open the capsule and sprinkle the beads on the fatty food ? Wouldn’t chewing the food then crush the bead? I'm dumbfounded once again.
Thanks,
Don’t Call Me Sprinkles
How can this be true?
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=74683&GoTopage=2&Category=2163&BzID=2258&t=1956&G=939
Elite Pharmaceuticals Reports Successful Pivotal Bioequivalence Study For Abuse Deterrent Product ELI-200
Northvale, New Jersey, Wednesday, March 05, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) announced today successful results from a pivotal bioequivalence study initiated in January 2014 for Elite’s undisclosed abuse deterrent opioid product, ELI-200. The study results demonstrated Elite’s product is bioequivalent to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) for opioid blood plasma levels. The study was a single dose, open label, partially randomized, three-way cross over study in healthy volunteers with 42 subjects under fasted conditions and 38 subjects under fed conditions.
Wow what's with the massive price drop ?? I've been alway for a few trading days and I look at this today and it's down 40% wth happend here?? Tia
Problem with Tmax delay under fed conditions. SequestOx issue only, not ADF tech issue.
The writing was all over wall, but the egos were too big to see it, thinking they knew better than the professional market types..which is comical. Much was known here of the issues which is why Eltp never moved higher like almost any company with a very highly likely approval would. There are smart people here who know the science part, but smart doesn't always equate into market saavy despite the desperate attempts of more than a few longs to claim otherwise.
Great question, John...
Why when you can sell at the open and buy back 2 or 3 times the ELTP shares later?
Dr. Pete, I'm with you.
I'm going to hold.
Elite Shareholder’s Prayer
O Benevolent Bid Supporter at Twenty,
I have always recognized Your Existence,
I have always appreciated Your Reinforcement,
Now look Graciously on your fellow shareholders,
O Benevolent Bid Supporter at Twenty,
Fortify Us with Your Mysterious Bid Support At Twenty.
(It’s more of a Gregorian chant than a prayer, really. Try it with the link below for three hours of healing chanting. Long & Strong, ELTP.)
We welcome our friends from the IPCI board.
crimsonreign
Man I'm glad Rexista got fast tracked by the FDA!
What are you talking about?
Also, the CRL description is exactly the same as many others' CRLs. It is that way because the FDA describes it that way.
Show any single example of that...
The mechanism is not what you think. A company must accept FDA labeling. If they do not, the FDA will send a CRL. It is not that the FDA is unwilling to approve generics. They just approved a hydrocodone/acetaminophen generic on July 5.
Things I assume, things I know.
I know there were no Phase 1 / Phase 2 study deficiencies. These would have been identified and addressed before Phase 3. I assume that in the three Phase 3 studies, NH did everything he was asked to do. I know the FDA deemed the application complete and appropriate for Priority Review.
In retrospect, I have to assume the lack of an AdComm means SequestOx was going to get a CRL from the start. I assume if it was a close call, there would have been an AdComm. Best case scenario, there is a technical violation in a Phase 3 study. Improper methodology of some sort caused the FDA to invalidate the results of one of the three studies. Simple study redesign and do over, resubmit NDA. I doubt that.
I know that KemPharm KP201/APAP AdComm gave thumbs up for approval but thumbs down for ADF label, and they got a CRL. I assume this is what happened to SequestOx today. I assume the FDA’s letter probably says something about our HAL studies being insufficient to support the ADF label. I assume there will be no more FDA approvals of NDA’s that do not get the ADF label. No more Oxaydo’s. If you do not qualify for ADF label, you get a CRL.
Why wouldn’t HAL deficiencies be identified prior to submission? I assume things changed. FDA Leadership changed, with prescription opioid abuse the hottest issue of the Senate hearing. The biggest change, though, was the Pfizer ALO-02 AdComm. I was shocked by their HAL results. First, I don’t think we’ve done anything near the kind of extraction studies that were done for ALO-02, some of which identified issues with crushed pellets that could be relevant to ELTP technology.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123214162
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123133533
Also, the oral abuse data was poor for ALO-02, which was surprising for an antagonist ADF. I do not believe any oral abuse studies were even done for SequestOx, because it is immediate release. IV abuse HAL studies are usually simulated and not human studies, but I’m not sure if they were done, either. We’ve only ever seen nasal abuse data and been told that it passed extraction studies, without any specific information about what kind of extraction studies were done. Yes, it passed all the tests, but it only took the remedial tests.
My best bet is that our problem with SequestOx is insufficient HAL studies. The good news, if this is true, is that SequestOx did not fail these studies. They have not yet been done. Pass the additional HAL studies, get approval with ADF label. I don’t know how long that would take, but it would be months not years.
I want to make additional comments about today’s PR. First, the company had the CRL yesterday, and waiting until close the next day (Friday) to release it is chicken-shit antics. That PR should have come out Thursday night. For the unnecessary extra 24 hours of anxiety, screw you Nasrat. Second, it’s obnoxiously god-awful bad. It contains a whole rambling paragraph incorrectly describing what a CRL is and then gives no details about the specific CRL they received. It does not need to spell out every detail, but those of us who hold our shares next week will pay for the lack of specificity. I can take my lumps and handle bad news, but when it comes in a disrespectfully-tardy PR that could have been better written by an 8th grader, then it does not help me to maintain my confidence in the professionalism of the organization.
The FDA issues CRLs to indicate that the Agency considers the review cycle for an application is complete and whether the application is ready for approval in its present form. CRLs often include guidance that describes deficiencies that the FDA has identified in the application. When possible, the FDA recommends actions that the applicant may take to place the application in condition for approval. The CRL determined that the NDA was not ready for approval in its present form.
Complete response letters will only be issued for applications that are not approved.
No such thing.
is there any of you smart people that think that we could have an IR of methadone and an ER
LPC sells their shares as they get them.
That could be the main reason LPC has been selling shares in the market during the past week so as to keep the pps down for price fixing
Just like John Langston said...
Correct and they haven't received any money yet on these new shares being registered and can't until the SEC declares the S-1 effective. You'll see a Notice of Effect hit EDGAR when that happens.
Let's approach it differently...
4000 docs x 10 Rx's/week x 52 weeks x 20 pills/Rx= 41,600,000 tablets of SequestOx per year. Let's say a conservative $5/pill, that would be revenue >$200,000,000/yr just from 10% of ER docs writing 10 scripts/week.
Great IV abuse potential with IR opioids.
The below study is a few years old, but it is very interesting because it uses doses typically available for immediate-release opioids. In other words, it is pretty obvious you will get nicely-stoned from injecting a crushed 30mg oxycodone IR or OxyContin 40mg, but most oxyIR is written as 5mg and 10mg. Do these smaller doses have similar abuse potential? This study tests these smaller doses and finds significant abuse potential, with oxycodone being the most potent. I've previously shown data from an FDA report in which 60% of oxyIR abusers endorse nasal abuse and nearly 40% report IV abuse of oxyIR within the past 30 days.
There is great potential for IV abuse of all opioids, including the smaller doses of immediate-release drugs, especially oxycodone. SequestOx has the potential to prevent 100% of IV and nasal abuse of immediate-release oxycodone, if universally adopted. The proprietary ELTP 2 bead antagonist ADF is fully modular and will be employed to prevent IV, nasal, and many forms of oral abuse for IR and ER formulations of every opioid agonist, including oxycodone, hydrocodone, morphine, oxymorphone, and hydromorphone.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2939200/
Intravenous Oxycodone, Hydrocodone and Morphine in Recreational Opioid Users: Abuse Potential and Relative Potencies
William W. Stoops,1,2,3 Kevin W. Hatton,4 Michelle R. Lofwall,1,2,5 Paul A. Nuzzo,1 and Sharon L. Walsh1,2,5
Abstract
Rationale
Nonmedical use and abuse of prescription opioids is an increasing public health problem. Intravenous (IV) administration of opioid analgesics intended for oral use is not uncommon, yet little is known about the relative abuse potential of these drugs when administered intravenously to recreational opioid abusers without physical dependence.
Methods
This inpatient study employed a double-blind, randomized, within-subject, placebo-controlled design to examine the relative abuse potential of IV doses of oxycodone, hydrocodone and morphine. Nine healthy adult participants reporting recreational opioid use and histories of IV opioid use completed 11 experimental sessions, including one active-dose practice session. IV doses were infused over 5-min and included three identical doses of each opioid (5, 10 and 20 mg/10 ml) and saline placebo. Physiological, subjective and performance effects were collected before and for 6 h after drug administration.
Results
All three opioids produced prototypical mu agonist effects (e.g., miosis; increased ratings of liking) that were generally dose-related. Pharmacodynamic effects were observed within 5 min of IV administration. Physiological effects were more prolonged than subjective effects for all three drugs. While the magnitude of effects was generally comparable across drugs and qualitatively similar, valid potency assays indicated the following potency relationship: oxycodone > morphine > hydrocodone.
Conclusions
There were modest potency differences between oxycodone, hydrocodone and morphine, but their overall profile of effects was similar, indicating significant abuse potential when administered intravenously.
Chris Christie's New Jersey
Where the Governor vetoes the ADF bill and receptionists prescribe oxycodone...
http://camdencountypros.org/detectives-arrest-voorhees-neurologist-office-receptionist-overprescribing-oxycodone-61516/
DETECTIVES ARREST A VOORHEES NEUROLOGIST AND OFFICE RECEPTIONIST FOR OVERPRESCRIBING OXYCODONE – 6/15/16
Dr. William R. Wolfe, M.D., who operated a neurological practice located in Voorhees Township, was arrested in connection with an investigation into the overprescribing of the addictive pain killer Oxycodone and other controlled dangerous substances. Dr. Wolfe’s receptionist, Lisa McIlhenny, was also arrested in connection with unlawfully writing prescriptions for Oxycodone.
Egalet's Oxaydo struggles without ADF label.
http://www.themarketdigest.org/201607/egalet-corp-eglt-files-form-4-insider-selling-mark-strobeck-sells-8700-shares/392066/
Other Insider transactions have been reported by the company according to SEC Form 4, on Jul 5, 2016, Jeffrey M. Dayno (Chief Medical Officer) sold 536 shares at $4.65 per share price.On Jul 5, 2016, Mark Strobeck (Chief Business Officer) sold 8,700 shares at $4.68 per share price.Also, On Apr 6, 2016, Robert S Radie (President and CEO) sold 5,000 shares at $6.99 per share price.On Apr 6, 2016, Deanne F. Melloy (Chief Commercial Officer) sold 860 shares at $6.96 per share price.
Your idea makes perfect sense, except...
Their legislature has moved to satiate their pharma lobbyists and their NJ drug manufacturers while looking like they are getting tough on Opioid drugs by not approving any ADF's.
So New Jersey is an anomaly in the ADF battle.
Remoxy AdComm is cancelled.
This is the third NDA submission for Remoxy (12 hour oxy physical barrier ADF), which received Complete Response Letters in 2008 and 2011. I have no idea if this is good for them or bad them.
http://finance.yahoo.com/news/pain-therapeutics-announces-advisory-committee-130000979.html
Pain Therapeutics Announces Advisory Committee Meeting for REMOXY® Is Not Needed
No Change to September 25th PDUFA Date
Pain Therapeutics, Inc.
July 1, 2016 9:00 AM
GlobeNewswire
AUSTIN, Texas, July 01, 2016 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (PTIE) announced today that the U.S. Food and Drug Administration (FDA) has determined that an Advisory Committee meeting for REMOXY, which had been tentatively scheduled for August 5th, is unnecessary and will not be held. FDA also advised that the regulatory review of the REMOXY NDA remains active and on-going. The Prescription Drug User Fee Act (PDUFA) date for the REMOXY NDA is unchanged.
REMOXY was previously the subject of an Advisory Committee meeting. In 2008, REMOXY was discussed by the FDA’s Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
Gov. Chris Christie vetoed NJ ADF Bill
http://www.politico.com/states/new-jersey/story/2016/01/christie-vetoes-abuse-deterrent-drugs-bill-amid-addiction-treatment-push-030209
Christie pocket-vetoed a bill (A4271), passed by both chambers in the final week of the legislative session, that would have required health insurance providers, including the State Health Benefits Plan and the School Employees’ Health Benefits Program, to cover abuse-deterrent opioids at the lowest level of cost-sharing.
While my dedication to addressing substance abuse is
strident, I cannot blindly approve any legislation related to
this issue. This bill would mandate health benefits coverage
for abuse-deterrent opioid analgesic drugs, which are developed
so that they cannot be crushed, dissolved, chewed or cut to
create a more potent and immediate effect. While the intent of
the bill is laudable, the benefits of such drugs are still
uncertain in the medical community and are the subject of ongoing
research. At least one medical journal, the New England
Journal of Medicine, has concluded that some drug abusers using
abuse-deterrent OxyContin, increase their use of other opioids,
including heroin. Therefore, it is simply too early to
determine whether this bill will accomplish its intended effect.
As Governor Cuomo similarly concluded in vetoing an analogous
bill, we need to further study this issue.
In addition to the lack of clarity regarding the efficacy
of these drugs, abuse-deterrent opioids cost approximately three
times more than opioids without these formulations. By all
accounts, this bill will cost the State over $11 million each
year, the benefits of which, as noted, are still uncertain.
When the SequestOx drug rep visits my office...
http://fortune.com/2016/06/21/doctors-cheaper-drug-prescriptions/
A Cheap Lunch From a Pharma Rep Can Influence Doctors' Prescriptions
by Ian Mount @ianmount JUNE 21, 2016, 7:56 AM EDT
The researchers found that doctors who were treated to a meal that was meant to promote the drug tended to prescribe that drug over equivalents. They were 18% more likely to prescribe Crestor (from AstraZeneca AZNCF 2.30% ) over over statins; 70% more likely to prescribe Bystolic (from Forest Laboratories) over other beta blockers; 52% more likely to prescribe Benicar (from Daiichi Sankyo) over other ACE inhibitors; and 118% more likely to prescribe Pristiq (from Pfizer PFE 0.77% ) over comparable antidepressants.
Counterfeit OxyIR 30mg
Similar to my previous post on heroin, dealers are substituting synthetic fentanyl for more desirable opioids, including OxyIR. Injecting fentanyl when they think they are injecting oxy or heroin is what is causing so many deaths. The abusers do not want the fentanyl, because it increases their tolerance to other opioids and requires them to use more, so the dealers are surreptitious in the fentanyl substitution (if you can't trust your oxy/heroin dealer, who can you trust?). When all generic oxyIR has been removed from the market and replaced by injection- and snorting-resistant ADF's like SequestOx, this danger will be resolved.
http://www.masslive.com/news/boston/index.ssf/2016/06/risk_of_overdose_boston_police.html
The illegal pills, marked up with A/215 like Oxycodone 30 mg tablets, are actually made out of Fentanyl, police said.
"Anyone who ingests these Fentanyl pills may put themselves in serious danger of overdosing which can result in death," police said in a release on their website.
It depends on the timeframe.
Elite signed the LPC deal in April 2013 when Elite was .07/share.
Through June 22, 2016, we have sold an aggregate of 79,082,073 shares of Common Stock to Lincoln Park under the Purchase Agreement for aggregate gross proceeds of approximately $21,906,602.
Lincoln Park Capital are not longs.
Obviously, these kinds of financing organizations do not generally discuss their business model, but the way they make their money is not hard to figure out. It basically involves churning most of the shares as they get them. If they keep any for long-term, it's probably not very many, and maybe only (some of) the free shares they get to initiate the deal. In this deal, they were given nearly 2,000,000 free shares. If they hold those for multiple dollars on buyout, then they did really good. But even if some company goes bankrupt after placing their maximum number of shares for purchase, then LPC still makes money because they're not holding those shares- they sold them immediately. They purchase the shares at a "discount," meaning most of their deals look like ours:
http://www.edgarexplorer.com/EFX_dll/EdgarPro.dll?FetchFilingConvPDF1?SessionID=rW33eSJCLxWji-9&ID=9920630
The purchase price per share for each such Regular Purchase will be equal to the lower of:
· the lowest sale price for our common stock on the purchase date of such shares; or
· the arithmetic average of the three lowest closing sale prices for our common stock during the 10 consecutive business days ending on the business day immediately preceding the purchase date of such shares.
This is flat-out false misinformation.
ELTP shares outstanding just increased by 8% just like that! It also means current shareholders were just DILUTED 8% of the value of their holdings since ELTP received NOTHING IN RETURN for 63,000,000 shares!
REPOST RE: YESTERDAY'S S-1
[The] S1 is a new prospectus for the old LPC II $40 million deal. It is required in order to continue to sell the shares to LPC as per the 2014 agreement. The original prospectus registered 108,000,000 shares for this purpose, and they have only placed about 80,000,000 of those shares since the start of the agreement. They need a new prospectus now because shares issued for warrants caused them to reach the total share count that would be outstanding if all the shares in the 2014 prospectus had been issued (668,000,000). They cannot place any more shares to LPC without this new prospectus.
The 63,000,000 shares in the today's prospectus includes ~26,000,000 that are already registered from 2014 and approximately 36,000,000 additional shares, for a new outstanding share count, if all shares are sold, of 793,000,000. This is all pursuant to the LPC II deal from 2014 for $40 million. There is nothing new here, except registration of more shares to cover the old deal. No new deals or placements of stock. None of these shares have yet exchanged hands, nor has any money. Posts that say otherwise are pure hooey.
Acetaminophen is a lame abuse-deterrent.
I have struggled to understand the concept of acetaminophen as an abuse-deterrent, which is essentially the FDA’s position regarding the hydrocodone and oxycodone combination products. They do not believe there is significant IV abuse, and they believe acetaminophen is an adequate aversive ADF for nasal abuse. This is specifically relevant to Elite’s development of ELI-202, which is presumed to be immediate-release oxycodone/acetaminophen combination with sequestered naltrexone. According to Nasrat Hakim, it makes no sense to add an expensive naltrexone bead to the capsules if the FDA does not believe your product will do more to deter abuse than inexpensive generic competitors. The latest data and thinking from the FDA on this subject was very recently described during the AdComm for KemPharm’s KP201/APAP. As part of their application, KemPharm asserted that hydrocodone acetaminophen products are regularly abused, and their product will prevent some of that abuse. They cited certain studies in their application, and some FDA lackeys prepared a summary report for the AdComm. It starts on Page 107 of this file:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM498784.pdf
My opinion is that the data in the report was incongruent with the conclusion of the report. They prove there is a significant amount of parenteral (non-oral) abuse of these products, especially in certain subgroups, but then they go on to conclude that parenteral abuse is inconsequential to the overall health burden in comparison to the rampant oral abuse of the same products.
5 CONCLUSION
The estimated prevalence of intranasal abuse among HCP abusers varies widely—from approximately 6% to more than 70%—depending on the setting and characteristics of the study population, how the questions about ROA are asked, and the referent time frame. The available data suggest that snorting is not an uncommon route of administration in certain populations of HCP abusers, particularly those with more advanced opioid addiction, those with polysubstance abuse, and high-risk adolescents. However, snorting is infrequently identified as the preferred or the exclusive route for abusing HCPs, and limited data suggest that regular (a few times a week or more) intranasal HCP abuse may be uncommon. Parenteral abuse of HCPs is reported very infrequently in all populations studied. Because of the widespread availability and abuse of HCPs, even a relatively low prevalence of intranasal abuse among HCP abusers translates to large absolute numbers of individuals exposed to potential harms associated with this behavior. Unfortunately, population data on harms associated with intranasal HCP abuse are very limited. However, the totality of the available epidemiologic data, interpreted in the context of the known pharmacologic properties of HCPs, suggests that intranasal abuse of HCPs may contribute relatively little to the overall public health burden of morbidity and mortality associated with HCP abuse, misuse, and addiction.
Option 5b: Eliminate combination Rx acetaminophen products
Current Situation Many Rx products contain acetaminophen in combination with other active ingredients. Consumers are not always aware when acetaminophen is present in Rx combination products and may take both OTC and Rx medicines containing acetaminophen at the same time, possibly resulting in overdose.
Option Eliminate combination Rx acetaminophen products.
Intended Effect This option could help prevent overdose by reducing the number of Rx products containing acetaminophen.
Considerations Related to Incidence of Hepatotoxicity (liver injury)
• Data from the 2005 Toxic Exposure Surveillance System show that 54% (1,470/2,698) of poison center calls involving acetaminophen-containing products that resulted in major injury involved Rx combination-products. (It is not clear how many of these injuries resulted from overdose of acetaminophen versus the narcotic component of the combination product.)
• A 275-patient study of acetaminophen-induced acute liver failure found that 63% of unintentionally overdosed consumers, and 18% of intentionally overdosed consumers had taken acetaminophen-containing narcotic products prior to injury.
• In the absence of combination hydrocodone–acetaminophen products, Rx NSAIDs are an alternative therapy. However, it is likely that many consumers receiving hydrocodone– acetaminophen products have already failed or are intolerant of NSAIDs for pain management. Other patients, who are getting ready to have surgery or recently had surgery, may not be able to use an NSAID when the risk of bleeding is a concern. The NSAID GI risk alone28 results in greater overall morbidity and mortality than the risk of serious hepatotoxicity with acetaminophen. The other alternative therapies are single ingredient Schedule II opioids, such as oxycodone, morphine, hydromorphone and oxymorphone. However, these are often desirable targets for misuse and abuse because abusers know they can take multiples of these without worrying about exposure to acetaminophen. Also, as these are Schedule II products, patients are required to fill prescriptions monthly to comply with the restrictions imposed by the Controlled Substances Act, rather than being able to obtain a three-month supply with one visit to the pharmacy. This could represent a substantial burden for elderly patients and others with limited mobility as well as for patients who live at a distance from a pharmacy.
Considerations Related to Implementation
• Hydrocodone–acetaminophen combination products are the most frequently prescribed analgesic and the most frequently dispensed Rx drug product in the United States.
• There are currently no approved single-agent hydrocodone products available in the United States. More than 240 NDA/ANDA combination applications would be affected by this option.
• For development of hydrocodone single-agent formulations, implementation would include:
– Submission of NDAs and ANDAs for single-ingredient hydrocodone products, which may also require clinical studies for demonstration of efficacy.
– Reformulation costs
I'll tell you this much,
they take this long
to make a decision...
they're gonna decide
to screw somebody.
Endo has controversial product, also.
Another ER product with an AdCom meeting and the FDA has discussed problems with ER products.
Endo Announces FDA Advisory Committee Meeting For OPANA® ER
Jun 15, 2016, 08:30 ET from Endo International plc
DUBLIN, June 15, 2016 /PRNewswire/ -- Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) (TSX: ENL), today announced that, based on discussions with the U.S. Food and Drug Administration (FDA), the Company has been notified that an Advisory Committee of the FDA will be convened in the fall of 2016 to review the Company's Supplemental New Drug Application (sNDA) for OPANA® ER. As a result of the Advisory Committee meeting, the current Prescription Drug User Fee Act (PDUFA) date of July 29, 2016 for the OPANA® ER sNDA will not be met and the action on the supplement is expected to be taken by the FDA as soon as possible following the Advisory Committee meeting.
The longest long-suffering long.
I remember when Bernard Berk gave the same speech, sort of makes me misty eyed with nostalgia
SequestOx approval is just the beginning.
Nasrat Hakim is building this company with a solid R&D foundation leading to organic growth of revenue from multiple products. He's been very consistent about this. No tricks or shortcuts. The real money is 3 years away. Expectations of sooner miracles are not based on what he has repeatedly stated, and what he confirmed again in the call this week.
From the time I have taken over as CEO, you’ve seen what was achieved in two years and 10 months; we went from $0.068 to about $0.30 plus. I have a vision, I have a plan I am executing on. I have a lot of people that have been pushing me to go to NASDAQ too early from former board members to top people on Wall Street and the answer is no. I have people trying to get me to borrow money and get in debt, so I can get projects going and the answer is conditional, and it’s mostly no. I will get us to where we are going in about three years. I am not going to lie to you about that and I am not going to pump up the stock or pump it down. I have a realistic plan that will get us where we are going.
Good calls, NASDAQ2020 and N2K.
NASDAQ has been saying for some time that ELI-202 is alive as oxy/acetaminophen without naltrexone, and that would be consistent with what NH said yesterday. N2K has been saying the SequestOx deal can, will, and should be revisited after the PuraCap takeover of Epic, and he was right on the money. I've only skimmed the transcript so far, but the dialogue below thankfully puts to rest two months worth of chatter: with the FDA, you don't know what will happen until it happens. All of his answers yesterday were both forthright and cautious. He expected an AdComm from the start and still believes there could be one, even after the PDUFA date is a possibility.
Three weeks to PDUFA date...
A watched pot never boils...
I need some kind of distraction...
Unidentified Analyst
Thanks very much, good morning. I have a couple of questions, so please don’t disconnect me after the first one. Good morning, Nasrat. Nasrat, what is the likelihood that you don’t get an AdCom meeting?
Nasrat Hakim
That is an outstanding question, I’ll tell you, everybody tells me, you’re going to get an AdCom meeting; we’re a 100% certain. From day one, I said well, yes, chances are, we’ll get one, but I’m not 100% certain we will. Maybe it’s 90% or 80%, but there’s a chance the FDA may decide because they’ve seen our technology; they’ve seen it in Embeda. And if you listen to the AdCom meeting for Pfizer, Dr. Hertz made a lot of positive comments about Embeda, which is the same technology as ours. And we are IR not an ER. So, there’s a small chance that they may not give us an AdCom meeting. However, the vast majority of people believe that it’s foregone conclusion and it’s coming some time soon.
Unidentified Analyst
So, if that happens, is it likely that the PDUDFA date get’s pushed out and if so by how much?
Nasrat Hakim
They actually -- the FDA doesn’t push out the PDUFA date, what they do is just say, your PDUFA date is this and your AdCom is let’s say in September. They never move the PDUFA date; at least they won’t for us, I don’t think. They’ll say when you get to the AdCom meeting, we’ll discuss the labeling, which is really the final step on what to write. But I don’t think they’re going to change the PDUFA date. It’s an interesting way of pushing the PDUFA date without pushing it. If they say, they’re going to make a decision in July 14, but then your AdCom is in September, then their final decision is after September.
IPCI's Rexista could be a first class drug! It was FDA Fast Tracked last year. They are filing NDA in July.
50% to Epic seems a little steep but maybe it was the best good deal Nasrat could swing
Elite will receive a license fee computed as a percentage (50%) of net sales of the Products as defined in the Agreement and is entitled to multi million dollar minimum annual license fees Elite will manufacture the product for sale by Epic on a cost plus basis